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The Post-Marketing Safety and Immunogenicity Research of Speeda® Rabies Vaccine for Human Use

Sponsored by Beijing Center for Disease Control and Prevention

About this trial

Last updated 10 years ago

Study ID

BJCDPC-5

Status

Completed

Type

Interventional

Phase

Phase 4

Placebo

No

Accepting

18-75 Years
All
All
All

Trial Timing

Ended 11 years ago

What is this trial about?

The objective of this study was to achieve the post-marketing safety and immunogenicity research of Speeda® rabies vaccine for human use from Chengda Bio

What are the participation requirements?

Yes

Inclusion Criteria

- Parent/legal acceptable representatives of children or the adult participants are willing and able to understand the protocol requirements and provide informed consent signed

- Participant is considered to be in good health including the body and mental status on the basis of reported medical history and limited physical examination and live in local ≥ 12 months

- Participant body temperature ≤ 37.0℃

- Participant without preventive inoculation of rabies vaccine(only limited in immunogenicity subgroup)

No

Exclusion Criteria

- Three-level exposure

- Known allergy to any constituent of the vaccine

- Reported the history of allergies, convulsions, epilepsy, mental illness and brain disease and clear serious systemic reaction

- Known bleeding disorder or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth

- Participation in any other interventional clinical trial

- An acute illness with or without fever (temperature > 37.0℃) in the latest week preceding enrollment in the trial

- Inoculated other vaccines, immunoglobulin or investigational drugs within 4 weeks prior to participation in the study

- Reported clearly the infection of the upper respiratory tract with 6 months Clinical Manifestation of Metabolic, blood system, lungs, heart, the gastrointestinal tract, nervous system, kidneys, urinary system, endocrine, liver disease or malignant tumor

- Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the vaccine